Agency: Department of Health and Human Services, National Institutes of Health

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, Center for Scientific Review, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Monica Basco, ECR Program, Center for Scientific Review, 6701 Rockledge Dr., Room 3220, Bethesda, MD 20892 or call non-toll-free number (301) 300- 3839 or Email your request, including your address to: CSRearlyCareerReviewer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Early Career Reviewer Program Online Application SystemCenter for Scientific Review (CSR), 0925- New Information Collection Request), Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviewsfree from inappropriate influencesso NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. The CSR Early Career Reviewer (ECR) program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. Currently, the application process involves repeated email interactions with potential applicants and manual management of information. To make the application process more efficient for applicants and for CSR staff, we are working with the Information Management Branch at CSR to develop online application software which includes the collection of applicants' names, contact information, and professional CV. This PRA clearance request is to develop online application software for ECR program applicants. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 650.

Agency: Department of Health and Human Services, National Institutes of Health

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 26, 2012, page 76053 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Nursing Research (NINR), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Agency: Department of Health and Human Services, National Institutes of Health

The purpose of this Request for Information (RFI) is to seek broad public input on the Fiscal Year (FY) 2013-2018 Strategic Plan for the Office of Disease Prevention (ODP), National Institutes of Health (NIH).

The Food and Drug Administration (FDA or ``we'') is reopening the comment period for a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013. We are reopening the comment period to update comments and to receive any new information.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels. Date and Time: The public conference will be held on May 1, 2013, from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and May 3, 2013, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, Fax: 513-679-2771, Gina.Brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. Early registration ends March 13, 2013. Standard registration ends April 9, 2013. There will be onsite registration. The cost of registration is as follows:

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) in support of efforts to inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.'' This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets. This guidance does not address specific finished-product release testing, where additional requirements may apply to scored tablets. This guidance does not describe the medical practice conditions under which tablet splitting is considered or recommended.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.